Stratified Therapy on Pediatric AAGN

Last updated: July 23, 2023
Sponsor: Wang Mo
Overall Status: Active - Recruiting

Phase

4

Condition

Dermatomyositis (Connective Tissue Disease)

Glomerulonephritis

Collagen Vascular Diseases

Treatment

GlucoCorticoid

Clinical Study ID

NCT05969522
ANCA20230706
  • Ages 5-17
  • All Genders

Study Summary

Clinical information of children with ANCA-associated nephritis admitted to Children's Hospital Affiliated to Chongqing Medical University and partner centers from January 1, 2023 to December 31, 2023 was collected:

To evaluate and compare the differences in survival, renal outcomes, and adverse reactions in children with ANCA-associated nephritis given different interventions according to the revised PARRG risk stratification, and to evaluate the superiority of ANCA-associated nephritis given according to the revised PARRG risk stratification.

(2) To evaluate the efficacy and safety of glucocorticoid combined with rituximab and cyclophosphamide as induction regimen in high-risk group and glucocorticoid combined with rituximab as induction regimen in children with ANCA-associated nephritis (AAGN) in low and middle risk group based on PARRG risk stratification

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Newly diagnosed AAGN patients with onset age of 5-17 years, complete renal biopsyand regular follow-up in the hospital; 2) All enrolled children met the followinginclusion criteria: ANCA classification criteria: Patients who meet the 2007 EuropeanMedicines Agency (EMA) classification algorithm or the 2012 CHCC definition. Clinicalclassification includes: micropolyvasculitis (MPA), granulomatous polyvasculitis (GPA)and eosinophilic granulomatous polyvasculitis (EGPA); AAGN diagnostic criteria: ANCA vasculitis combined with any of the following:
  1. Hematuria: gross hematuria or microscopic hematuria: 3 times microscopic hematuriawithin 1 week: red blood cells &gt in urine routine; 3 / high magnification field (HP)or > 17 /ul (higher than normal value, can be adjusted according to the standard ofthe laboratory of each center);
  2. proteinuria: meet any of the following: ① 3 times in 1 week urine routine proteinpositive; 2) 24h urinary protein quantification > 150 mg or urinaryprotein/creatinine (mg/mg)> 0.2; 3 urinary microalbumin higher than normal for 3times in 1 week;
  3. Renal insufficiency: increased serum creatinine > 10% base or decreased creatinineclearance > 25%.

Exclusion

Exclusion Criteria:

    1. Patients who relied on dialysis for more than 1 month at the time of diagnosis, or theproportion of glomerular sclerosis ≥75% at the time of renal biopsy; 2) Patients withsevere infection (such as diffuse peritonitis, severe pneumonia, cellulitis, activeEpstein-Barr virus infection, active cytomegalovirus infection, hepatitis B virusinfection, tuberculosis infection, fungal infection, etc.) and tumor.
  1. Patients with other primary or secondary kidney diseases (such as IgA nephropathy,membranous nephropathy, anti-glomerular basement membrane nephritis, polycystic kidneydisease, renal dysplasia, urinary tract malformation, etc.); 4) Parents or children refusedto join the group.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: GlucoCorticoid
Phase: 4
Study Start date:
January 01, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing 400015
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.